Senior Regulatory Affairs Specialist

Eko

6d•$138,147 - $192,999•Remote

About The Position

Eko Health is pioneering AI-powered cardiovascular care by placing advanced digital stethoscopes, ECG hardware, and FDA-cleared AI algorithms into the hands of clinicians worldwide. In this pivotal role as Senior or Principal Regulatory Affairs Specialist, you will support business objectives by leading high-impact regulatory remediation, overseeing global international expansion across clinical and veterinary markets, and spearheading regulatory strategy for cutting-edge software and hardware platforms.

Requirements

Bachelor’s or Master’s/advanced degree in Engineering, Life Sciences, Regulatory Affairs, or related technical discipline.
5–8+ years of progressive regulatory affairs experience in medical devices, digital health, and/or SaMD (Software as a Medical Device).
Strong working knowledge of FDA 21 CFR 820 / QMSR, EU MDR 2017/745, ISO 13485, and global regulatory submissions.
Direct experience writing/submitting 510(k)s, Q-Subs, De Novo, Technical Files, and managing Notified Body reviews.
Proven track record leading major QMS remediation programs and global market entries.
Strong communication, organizational, and problem-solving skills.
Ability to perform the essential functions of the role with or without reasonable accommodation.

Nice To Haves

RAC (Regulatory Affairs Certification) preferred.
Experience in a startup or high-growth environment.

Responsibilities

Lead architectural QMS and regulatory remediation, aligning global procedures into unified, streamlined workflows.
Revise and consolidate SOPs for Design History File (DHF), Design and Development Files, Post-Market Surveillance (PMS), Labeling/UDI, EUDAMED, and global Regulatory Strategy to conform with FDA QMSR and ISO 13485.
Drive regulatory documentation cleanup and maintain the Global Regulatory Submissions & Deficiencies Database.
Inform global registration strategies and submission execution across EU (MDR), UK (UKCA/SGS transition), Canada, APAC, and LATAM markets.
Manage interactions with Notified Bodies and EU Authorized Representatives for technical file reviews, Notifications of Change (NoC), and DoC/CE updates.
Support regulatory evaluation and intelligence mapping for Eko Vet+ rollout across global territories.
Serve as the RA representative on core project teams for hardware and AI/software releases.
Standardize claims matrices, IFU restrictions, and advertising/promotional review processes across commercial and life science units.
Evaluate and implement Regulatory Information Management Systems (RIMS) and AI-native workflows.
Ensure compliance with company policies and applicable laws.
Other duties as assigned.